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OpenTrials
Completed

NCT Number: NCT05339724

Platelets in Cystic Fibrosis Lung Inflammation

Cystic fibrosis (CF) is a chronic multiorgan disorder caused by mutations in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Chronic airway infection by bacterial pathogens accounts for the progressive, suppurative pulmonary disease that leads to significant morbidity and mortality in patients with CF. Neutrophil recruitment to the lungs accounts the most important contributor to pulmonary destruction. However, there is evidence that platelets may also have an important role in the pathogenesis of inflammation. To our knowledge, there is few information in platelet levels in patients with cystic fibrosis during pulmonary exacerbation, chronic airway colonization and when stable.

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Key information

Age range

12 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mersin City Research & Training Hospital

Mersin, Turkey (Türkiye)

About this study

Airway inflammation in CF is predominantly neutrophilic in nature with increased concentrations of pro-inflammatory mediators include TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-33, GM-CSF and G-CSF. In addition, other cell types including macrophages and T-lymphocytes are expressed by CFTR and contribute to the CF inflammatory response.

Researches have indicated that platelets may also have a significant contribution to the inflammation. Platelet depletion or antiplatelet therapies attenuate injury and mortality in animal models of acute lung injury. More importantly, CFTR expression has been shown on human platelets. Recent data suggests that CF patients have an increase in circulating activated platelets and platelet reactivity.

Taken together, these observations support a potentially important role of platelets in regulating lung inflammation in CF. However, there are few studies examine platelet and lung inflammation interraction in patients with CF. Therefore we aimed to investigate platelet count (PC) and mean platelet volume (MPV) levels in various conditions in our CF patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All regularly followed cystic fibrosis patients with clinical and laboratory results could be obtained from medical charts.

Exclusion criteria

  • None

Treatment and study plan

platelet count and mean platelet volume are obtained from whole blood count

Other

The records of cystic fibrosis patients will be retrospectively evaluated for acute pulmonary exacerbation, chronic airway colonization for bacteria, clinical stable status. PC and MPV will be obtained and matched in 6 groups (described above). Then, PC and MPV will be compared among the groups.

Primary outcomes

  1. Platelet levels and mean platelet volume in acute pulmonary infection in patients with cystic fibrosis

    Time frame: 2 weeks

    Elevated platelet level count (x103/uL) and increased mean platelet volume (fl) during acute pulmonary exacerbation in cystic fibrosis patients

Sponsors and collaborators

Lead sponsor

Mersin Training and Research Hospital

Other Gov

Registry information

Official study title

Platelets: A Neglected Cell in Cystic Fibrosis Lung Inflammation

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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